The MHRA has recently published a guidance for handling of centrally authorised products (CAPs) with assessment pending on EU exit day. Although the document is concerned with a no-deal scenario, it may also provide an accurate framework in the event of an ordered Brexit, depending on the exact nature of the final withdrawal agreement. An easy-to-understand overview has been published here, which succinctly tabulates stakeholder options in chronological order. Unsurprisingly, these options are determined by the assessment process’ progression, with major changes to procedures occurring at days 120, 180 and 210. Details on these options are listed in the second part of this article.
One alternative route for assessment exists throughout the course of the 210 day assessment process, namely awaiting day 210 CHMP opinion and subsequently applying for MHRA’s new ‘targeted assessment’. This route arguably uses agency resources most efficiently and thereby helps both the EMA and particularly the MHRA to manage their increased workloads during Brexit. Importantly, applicants may also be able to significantly save on agency fees when pursuing this route.
Biosimilars and products containing a new active substance are eligible for targeted assessment, as long as they have received positive CHMP opinion in the Centralised Procedure (CP). The applicant is obliged to submit the entire CTD sequence of the original EMA application plus all sequential CHMP assessment reports from day 120 onwards. In order to achieve MHRA timelines for 67-day assessment, applicants are asked to submit for targeted assessment no longer than three days after day 210 CHMP opinion. This is crucial in order to receive European Commission (EC) and MHRA approvals at around the same time, enabling launching the new product in both markets simultaneously.
During the first six weeks (day 42) of the 67 day assessment cycle, the MHRA will consult with the Commission on Human Medicines (CHM) and will reach a provisional conclusion on the new medicinal product. Any outstanding issues, for instance UK specific points related to the Risk Management Plan (RMP), should be addressed during the remaining 25 days of the procedure. In the unlikely event of a gross discrepancy of opinions between MHRA and CHMP in terms of a serious risk to public health, the MHRA will request further information from the applicant. The regular appeal process for National procedures will be followed, including changing to a day 150 timetable (as in the Decentralised or Mutual Recognition Procedures; DCP, MRP).
In the event of an applicant not wanting to await CHMP day 210 opinion, MHRA has published several alternative routes. Here, the overarching goal was to support individual business needs.
Submissions up until day 120
For medicinal products in the initial phase of assessment, applicants may choose to seek an independent assessment by the MHRA. Fees and guidelines for National procedures apply.
Submissions between day 121 and day 180 – ‘In flight assessment’
In addition to the original CTD sequence, the applicant submits the list of day 120 questions along with responses. This enables the MHRA to kick-start an independent assessment while the EMA CP is carried out in parallel. MHRA will discuss and assess this new application with the CHM, with the objective to reach a decision no longer than 60 days after the starting date.
Submissions at day 181 and beyond
The applicant submits the entire original CTD sequence, the lists of questions for day 120 and day 180 plus their respective responses. The MHRA then takes over by assessing any outstanding issues and reaches a decision in a timely manner.